Orudis (ketoprofen)

Orudis capsules and suppositories contain the active ingredient ketoprofen, which is a type of medicine called a non-steroidal anti-inflammatory drug (NSAID). NSAIDs are used to relieve pain and inflammation. (NB. Ketoprofen is also available without a brand name, ie as the generic medicine.)

23/05/2008

What is it used for?

In adults, relief of pain and inflammation in a wide range of conditions, including those listed below.

How does it work?

Orudis capsules and suppositories contain the active ingredient ketoprofen, which is a type of medicine called a non-steroidal anti-inflammatory drug (NSAID). NSAIDs are used to relieve pain and inflammation. (NB. Ketoprofen is also available without a brand name, ie as the generic medicine.)

Ketoprofen works by blocking the action of a substance in the body called cyclo-oxygenase (COX). Cyclo-oxygenase is involved in the production of various chemicals in the body, some of which are known as prostaglandins. Prostaglandins are produced by the body in response to injury and certain diseases and conditions, and cause pain, swelling and inflammation. Ketoprofen blocks the production of these prostaglandins and is therefore effective at reducing inflammation and pain.

Ketoprofen is used to relieve pain and inflammation in a wide range of musculoskeletal conditions, including various forms of arthritis, gout, muscle sprains and strains, back pain, neck pain and tendinitis. It can also be used to relieve period pain.

Orudis capsules should preferably be taken with food to help avoid irritating the stomach.

Orudis suppositories melt in the rectum and the ketoprofen is then absorbed into the bloodstream through the rich supply of blood vessels found in this area. The suppositories are used to provide pain relief at night, and if necessary are used in combination with capsules taken by mouth during the day.

Warning!

Orudis capsules should be taken with or after food to help avoid irritating the stomach.

Orudis suppositories are for rectal use only and must not be taken by mouth.

This medicine may cause dizziness and so may affect your ability to drive or operate machinery safely. Do not drive or operate machinery until you know how this medicine affects you and you are sure it won't affect your performance.

Your doctor will prescribe you the lowest effective dose of this medicine for the shortest possible time necessary to relieve your symptoms. This is to minimise the chances of any side effects, particularly those mentioned below. It is important not to exceed the prescribed dose.

NSAIDs can occasionally cause serious side effects on the gut, such as ulceration, bleeding or perforation of the stomach or intestinal lining. This type of side effect is more likely to occur in elderly people and in people taking high doses of the medicine. The risk can also be increased by taking certain other medicines (see below). It is important that these people, as well as people with a history of disorders affecting the stomach or intestines, are closely monitored by a doctor while taking this medicine. If your doctor thinks you are at high risk of side effects on the gut you may be prescribed an additional medicine to help protect your gut. All people taking this medicine should stop treatment and consult their doctor immediately if they experience any sign of bleeding from the stomach or intestine during treatment, for example vomiting blood and/or passing black/tarry/bloodstained stools.

Studies have suggested that use of some NSAIDs may be associated with a small increase in the risk of heart attacks and stroke (particularly if used in high doses or for long periods of time). If you have risk factors for heart disease or stroke, such as diabetes, high blood pressure, high cholesterol or smoking, your doctor will need to assess the overall benefits and risks before deciding if this medicine is suitable for you. Ask your doctor or pharmacist for further information.

Very rarely, NSAIDS may cause serious blistering or peeling skin reactions (eg Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis). For this reason, you should stop taking this medicine and consult your doctor if you get a skin rash or sores inside your mouth while taking this medicine. This side effect is very rare, but if it occurs, is most likely to happen in the first month of treatment.

If you have cirrhosis of the liver, heart failure or kidney disease, or you are taking diuretic medicines, your kidney function should be assessed before starting and regularly throughout treatment with this medicine.

During long-term treatment with this medicine you should have regular check-ups with your doctor so that you can be monitored for possible side effects of the medicine. This might include routine blood tests to monitor your kidney function, liver function and levels of blood components, particularly if you are elderly.

Not to be used in

People in whom aspirin or other NSAIDs, eg ibuprofen, cause allergic reactions such as asthma attacks, itchy rash (urticaria), nasal inflammation (rhinitis) or swelling of the lips, tongue and throat (angioedema).

Orudis suppositories should not be used in people with piles (haemorrhoids) or inflammation of the rectum (proctitis).

This medicine is not recommended for children.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

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Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

This medicine is not recommended for use in pregnancy unless considered essential by your doctor. This is particularly important in the first and third trimesters. If taken in the third trimester it may delay labour, increase the length of labour and cause complications in the newborn baby. Some evidence suggests that NSAIDs should also be avoided by women attempting to conceive, as they may temporarily reduce female fertility during treatment and may also increase the risk of miscarriage or malformations. Seek medical advice from your doctor.

This medicine may pass into breast milk, but in such small quantities that it is unlikely to harm the baby. However, the manufacturer recommends that this medicine is avoided by women who are breastfeeding, unless it is considered essential by your doctor. Seek medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

Retention of water in the body tissues (fluid retention), resulting in swelling (oedema).

Mood changes.

Difficulty sleeping (insomnia).

Ulceration in the stomach or intestine.

Bleeding from the stomach or intestine.

Allergic reactions such as skin rashes, swelling of the lips, tongue and throat (angioedema) or narrowing of the airways (bronchospasm).

Abnormal reaction of the skin to light, usually a rash (photosensitivity).

Kidney, liver or blood disorders.

Visual disturbances.

Sensation of ringing or other noise in the ears (tinnitus).

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The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before taking this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to ensure that the combination is safe.

Ketoprofen should not be taken in combination with painkilling doses of aspirin or any other oral NSAID, eg ibuprofen, as this increases the risk of side effects on the stomach and intestines. Selective inhibitors of COX-2 such as celecoxib or etoricoxib should also be avoided for the same reason.

There may be an increased risk of ulceration or bleeding in the gut if ketoprofen is taken with corticosteroids such as prednisolone.

There may also be an increased risk of bleeding in the gut if ketoprofen is taken with the following medicines:

anti-blood-clotting (anticoagulant) medicines such as warfarin or heparin

Ketoprofen may enhance the effect of blood-thinning or anti-clotting medicines (anticoagulants) such as warfarin. As this may increase the risk of bleeding, people taking ketoprofen with an anticoagulant should be closely monitored by their doctor.

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Ketoprofen may reduce the removal of the following medicines from the body and so may increase the blood levels and risk of side effects of these medicines. People taking ketoprofen with any of these should be closely monitored by their doctor:

lithium

methotrexate.

There may be an increased risk of side effects on the kidneys if ketoprofen is taken with any of the following medicines:

ACE inhibitors, eg enalapril

ciclosporin

diuretics, eg furosemide

tacrolimus.

Ketoprofen may oppose the blood pressure lowering effects of certain medicines to treat high blood pressure, such as the following:

ACE inhibitors such as captopril

beta-blockers such as propranolol

diuretics such as furosemide.

Probenecid may increase the blood level of ketoprofen, which may increase the risk of side effects.

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